Brand Name | DAILY ACTIVITY ASSIST DEVICES |
Type of Device | 890.5050 |
Manufacturer (Section D) |
HENYI ENTERPRISE |
no. 386-3 qingnian street |
heping district |
shenyang 1100 04 |
CH 110004 |
|
MDR Report Key | 3768688 |
MDR Text Key | 4549709 |
Report Number | 1531186-2014-01505 |
Device Sequence Number | 1 |
Product Code |
IKX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/23/2014,03/27/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/23/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 7740P |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/23/2014 |
Distributor Facility Aware Date | 03/27/2014 |
Device Age | 8 MO |
Date Report to Manufacturer | 04/23/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|